2 INTERVENTIONAL PROCEDURES PROGRAMME NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE REVIEW BODY REPORT Title A systematic review of the safety and efficacy of elective photorefractive surgery for the correction of refractive error. Produced by Health Services Research Unit University of Aberdeen Polwarth Building Foresterhill Aberdeen AB25 2ZD In collaboration with Department of Health Services Research School of Health and Related Research University of Sheffield Regent Court Sheffield S1 4DA The Review Team Alison Murray, Lisa Jones, Anne Milne, Cynthia Fraser, Tania Lourenco, Jennifer Burr Correspondence to Jennifer Burr Clinical Research Fellow Health Services Research Unit University of Aberdeen Polwarth Building Foresterhill Aberdeen AB25 2ZD Tel: (01224) Fax: (01224) ; Date completed April 2005 ii

3 Home units details The Health Services Research Unit (HSRU) is a multidisciplinary research group of about 50 people based in the University of Aberdeen. The Unit is core-funded by the Chief Scientist Office of the Scottish Executive Health Department, and has responsibility for the following general remit: 1. To study or evaluate clinical activities with a view to improving effectiveness and efficiency in health care; 2. To work for the implementation of proven changes in clinical activities; 3. To encourage and support similar work thoughout Scotland; 4. To train NHS staff in Scotland, and others, in the principles and practice of health services research in general, and health care evaluation in particular. The Unit has an established portfolio of health services research focusing on two main programmes health care assessment and delivery of care. The Unit is one of the three research groups that make up the Review Body for the National Institute for Clinical Excellence Interventional Procedures Programme. The other is based at the University of Sheffield in the School of Health and Related Research (ScHARR). ScHARR brings together a wide range of health related skills including: health economics, operational research, management sciences, epidemiology, medical statistics, and information science. There are also clinical skills in general practice and primary care, psychiatry, rehabilitation and public health. ScHARR employs about 200 multidisciplinary staff and attracts in excess of 4 million per year in external support. ScHARR is organised into seven sections, including the Health Services Research Section, which consists of four academic groups covering research into acute and critical care, complementary medicine, primary care, long-term conditions, emergency and immediate care, and social sciences and health. Contributions of authors Alison Murray commented on the scope, screened the LASIK search results, assessed full text LASIK papers for inclusion, undertook data abstraction and quality assessment of LASIK studies, drafted the methods and LASIK sections of the review, and contributed to the writing of the rest of the review. Lisa Jones screened the PRK search results, assessed full text PRK papers for inclusion, undertook data abstraction and quality iii

4 assessment of PRK studies, drafted the PRK section of the review, and contributed to the writing of the rest of the review. Anne Milne screened LASEK search results, assessed full text LASEK papers for inclusion, undertook data abstraction and quality assessment of the LASEK studies, drafted the LASEK sections of the review, and contributed to the writing of the rest of the review. Cynthia Fraser developed and ran the literature search strategies, obtained papers and formatted the references. Tania Lourenco contributed to writing the background, unpublished data, quality assessment and appendices. Jennifer Burr wrote the scope for the review and the conclusions, contributed to writing the background, discussion, unpublished data and executive summary, commented on the rest of the review and provided a clinical oversight. Conflict of interest None Acknowledgements We thank Bruce Allan (Consultant Ophthalmic Surgeon, Moorfields Eye Hospital), Paul Rosen (Consultant Ophthalmic Surgeon, Oxford Eye Hospital and President Elect of the UK and Ireland Society of Cataract and Refractive Surgeons) and Catharine Chisholm (Research Fellow, Applied Vision Research Centre, City University London and Vice President of the British Society for Refractive Surgery) for providing specialist advice and commenting on the draft of the report, Adrian Grant (Director, HSRU) and Brian Ferguson (Univerisity of York) for commenting on the draft of the report, Bronwyn Davidson (Reviews Secretary, HSRU) and Kathleen McIntosh (Senior Secretary, HSRU) for helping to format the manuscript and Jonathan Cook for assistance with statistical analysis. The Health Services Research Unit receives a core grant from the Scottish Executive Health Department. The views expressed are those of the authors and not necessarily those of the funding bodies. Special thanks also go to Bruce Allan, Dr H Hashemi, Dr M Camellin and Dr P Condon for providing additional information for published studies and Dan Reinstein (London Vision Clinic) for providing unpublished data. iv

15 EXECUTIVE SUMMARY Background Refractive error includes myopia, hyperopia, astigmatism and presbyopia; these are usually corrected by wearing spectacles or contact lenses. Modifying the shape of the cornea can reduce myopia, hyperopia and astigmatism. Corneal reshaping is achieved in photorefractive surgery using excimer laser ablation and is indicated in the range of refractive error from +6 dioptres (D) of hyperopia to 10 D of myopia, with up to 4 cylinders of astigmatism. This surgery is widely available in the private sector but is not performed as an NHS procedure unless indicated for therapeutic reasons. Excimer laser refractive surgery techniques in current use include photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK) and laser in-situ keratomileusis (LASIK). PRK involves the removal of the corneal epithelium and ablation of the corneal stromal bed. LASEK is a modification of PRK but instead of completely removing the epithelium, dilute alcohol is used to loosen the epithelium, which is lifted from the treatment zone as a hinged sheet and is swept back into place at the end of surgery. In LASIK, a flap is created with a microkeratome, this is lifted, the underlying corneal stromal bed is ablated, and the flap is repositioned. LASIK has been performed in the UK since Initially it was used to treat higher levels of myopia not suitable for PRK but now it has become the dominant technique for correction of refractive error. Ectasia due to weakening of the cornea is the most serious complication of refractive surgery. Risk factors are high myopia, keratoconus, and a residual cornea\thickness after ablation of less than 250 µm. Assessment for suitability for the procedure requires an appropriate medical, ophthalmological and occupational history followed by a comprehensive ophthalmological examination; in particular to assess the front and back surface of the cornea (corneal topography) and measure of corneal thickness. Other important potential adverse effects of photorefractive surgery include reduced best spectacle corrected visual acuity, infection and problems related to overall visual performance such as glare, halos and difficulties in low light conditions. Objective To systematically review the evidence for safety and efficacy of PRK, LASEK and LASIK for the correction of myopia, hyeropia and astigmatism. xv

16 Number and quality of included studies Only papers published from 2000 onwards were included in the review. From the initial 3036 reports identified by the search strategy, 40 case series were included in the review of PRK, 26 case series published in 40 reports in the review of LASEK, and 64 case series published in 73 reports in the review of LASIK. For studies with multiple publications only the most up-to-date report was considered. In addition, 11 randomised controlled trials (RCTs) comparing PRK and LASEK, three RCTs comparing LASEK and LASIK, and two RCTs comparing PRK and LASIK, were included in the review. More evidence was available for LASIK than for PRK and LASEK (total number of eyes in case series were 293,278, 15,785 and 5,091, respectively). Nine of the LASEK case series were only published as abstracts. Some of the studies had high drop-out rates and this raises questions about the reliability of the results. Direct comparisons between techniques could be made using evidence from the RCTs. However, the RCTs were too small to reliably identify differences in rare adverse events. Summary of evidence of safety Comparisons between the PRK, LASEK and LASIK case series must be made with care as sample sizes, participant populations, length of follow-up, surgeon experience and technologies differ. The median event rates were presented due to the high degree of heterogeneity. Incidence of ectasia was only reported in five LASIK studies, median rate 0.2% (range 0% to 0.87%). However, on review, six of the 40 eyes with ectasia had preoperative topography suspicious of keratoconus, which is a contraindication to LASIK. The majority of remaining eyes (28 out of 34 eyes) had a residual layer of cornea below 250 µm. After exclusion of these cases, the median rate was 0%. Microbial keratitis was also only reported in LASIK studies and occurred in 0% to 0.16% of eyes. The median rate of loss of two or more lines of best spectacle corrected visual acuity (BSCVA) was 0.5%, 0% and 0.6% of myopic and myopic astigmatic eyes treated with PRK, LASEK and LASIK respectively. Eyes treated for high myopia were more likely to lose two or more lines of BSCVA than eyes treated for low to moderate myopia. The overall median rate of 7.0% of hyperopic eyes treated with hyperopic-prk (H-PRK), and xvi

17 3.5% treated with LASIK, were reported to lose two or more lines BSCVA. H-PRK for hyperopia of > D was more likely to result in loss of lines of BSCVA than treatment for lower levels of hyperopia. Only one study (an RCT) included eyes with hyperopia treated by LASEK; this reported no eyes losing more than two lines BSCVA. Flap complications may occur in LASIK and LASEK; these may result in postponement of ablation (LASIK), conversion to PRK, or occasionally loss of BSCVA. Buttonhole flaps and incomplete flaps were reported in 0.1% and 0.3% of LASIK eyes and free caps (where the hinge is cut) in 0.1%. Epithelial ingrowth was reported in 1.3% of LASIK eyes. Diffuse lamellar keratitis occurred in 1.4% of eyes receiving LASIK. Outcome after diffuse lamellar keratitis was unclear because this was rarely reported; when it was reported eyes rarely lost vision after resolution of diffuse lamellar keratitis. Approximately 2% (range 0% to 19%) of LASEK treatments were converted to PRK due to flap complications. Severe early post-operative pain was reported for PRK (range 1.3% to 3.8%) and LASEK (range 0% to 19%) in case series. Conflicting results were reported in RCTs comparing pain following PRK and LASEK and meta-analysis suggested no significant difference between the two treatments. Occurrence of significant corneal haze was reported following all three procedures; in 0% to 31% of PRK eyes, 0% to 25% of LASEK eyes, and 0% to 2.0% of LASIK eyes, although definition of haze varied between studies, particularly for LASIK. Less corneal haze was reported following LASEK than PRK in RCTs. Reports of subjective visual outcomes following refractive surgery varied. Glare and night vision were worse after PRK in 55% and 32% of participants respectively. Glare and night driving difficulty were less common after LASIK, although dry eye and fluctuations of vision were more common. There was no significant difference between PRK and LASIK in change in glare or halo symptoms following treatment in one RCT. Intraocular pressure was not found to be persistently raised following photorefractive surgery and none of the included studies reported cases of glaucoma after PRK, LASEK or LASIK. The incidence of retinal detachment was below the reported incidence for people with similar levels of myopia who have not undergone refractive surgery. xvii

18 Summary of evidence of efficacy Overall, for the three treatments, correction of myopia and myopic astigmatism, the median rates were between 68% to 75% of eyes achieving within 0.5 D of their intended spherical equivalent correction and around 86% to 92% of eyes achieved within 1.0 D. Eyes with low to moderate myopia treated by PRK or LASIK appeared more likely to achieve their intended correction than eyes with high myopia. There were insufficient data to determine the effect of different levels of myopia on the accuracy of LASEK. There were no significant differences in accuracy between the three procedures for myopia or myopic astigmatism in any of the RCTs. The accuracy of photorefractive surgery was lower for hyperopic correction; a rate of around 61% of eyes achieved within 0.5 D of intended correction after PRK and LASIK. Seventy-nine and 88% for PRK and LASIK respectively were within 1.0 D. Eyes with hyperopia of <+3.50 D were more likely to achieve the intended correction after PRK than eyes with higher hyperopia. One RCT found LASEK to be significantly more accurate than PRK for eyes with hyperopia. Retreatment rates depend on the criteria for retreatment. Between 0.7% and 25.8% of PRK or PARK and 0% and 6% of LASEK eyes were reported to be retreated. Retreatment for under or over-correction was common after LASIK; 11% of myopic eyes and 12% of hyperopic eyes were retreated. More eyes with high myopia (23%) than low to moderate myopia (3%) were retreated after LASIK. Uncorrected visual acuity (UCVA) of 20/20 or better was achieved at last follow-up in 70%, 62% and 64% respectively of myopic eyes treated with PRK, LASEK and LASIK, and 20/40 or better in 92%, 92% and 94%, respectively. Highly myopic eyes achieved 20/20 UCVA in 14% and 44% compared with 76% and 81% for low to moderately myopic eyes treated with PRK and LASIK respectively. There were insufficient data to identify trends in the efficacy of LASEK at different levels of myopia. Overall, 59% of H- PRK treated hyperopic eyes and 52% of LASIK treated hyperopic eyes achieved an UCVA or 20/20 or better with 86% to 96% achieving 20/40 or better. No RCT reported any significant difference between PRK, LASEK or LASIK in UCVA at six months. xviii

19 Conclusions The safety and efficacy of photorefractive surgery should be considered against the alternative methods of correction: spectacles and contact lenses. Also, the surgical technologies are changing rapidly and some lasers and microkeratomes used in studies reviewed have been superseded. The review of efficacy found broadly similar performance for PRK, LASEK and LASIK. Participants with a milder degree of myopia were more likely to achieve the intended refractive correction. myopia. Treatment of hyperopia was less successful than treatment of Most adverse events were statistically rare. It was unclear what effect refractive surgery had on commonly reported subjective visual symptoms, such as dry eye and night driving difficulty. The safety profiles of PRK, LASEK and LASIK reflected their technical differences: corneal haze was more common after PRK; flap problems followed LASEK and LASIK. The most serious problem, ectasia, was only reported after LASIK. Review of the cases of ectasia confirmed the importance of appropriate patient selection and treatment: the majority were found to have a contraindication to LASIK or to have received inappropriate treatment. xix

21 GLOSSARY Aberration A deficiency of the optical system in which light rays are scattered thereby degrading the optical image o Lower order aberration Collective term for refractive errors; myopia, hyperopia and astigmatism o Higher order aberration Collective term for a series of imperfections in the eye s optical system that may lead to vision problems, particularly low light vision difficulties Broad Beam A laser with a relatively large (6-8mm) diameter beam for ablation Cornea The transparent, avascular convex front surface of the eye. The cornea is made up of five layers, and the average corneal thickness is approximately 550 µm. Reproduced with permission of Leo D. Bores, MD (substantia propria is commonly known as the stroma) Closed-loop A constant connection between eye tracking device and the laser system to influence the placement of the beam Customised ablation The use of a wavefront sensing system and a flying spot excimer laser to treat the lower and higher order aberrations Decentration A complication of refractive surgery. In perfect centration the centre of the corneal ablation exactly coincides with the centre of the visual axis, and or pupil. xxi

22 Decentration can cause symptoms such as edge glare or monocular double vision (diplopia) Diffuse Lamellar Keratitis An inflammation under the LASIK flap of the cornea, believed to be in response to the presence of sterile infiltrates in the flap interface. Dioptre Unit of measurement for the power of a lens or of refractive error Epithelial Ingrowth A LASIK complication wherein epithelial cells proliferate underneath the corneal flap Ectasia Refractive instability associated with a corresponding progressive structural corneal deformation Enhancement - A re-treatment procedure to further reduce the refractive error Eye tracker A system for tracking involuntary movements during refractive surgery to ensure accurate beam placement Flying spot laser The latest generation excimer laser that uses a small (1mm-2mm) diameter treatment beam to precisely sculpt the cornea Gaussian beam A type of small-spot laser beam with a unique round shape for smooth ablation Glare Points of light look brighter and indistinct Haloes A point of light appears to have rings of light around it Haze The cornea is not clear, and is graded on a four-point scale 0-4, > grade 2 is clinically significant and can reduce vision Keratoconus A disease of the cornea leading to a cone shape protrusion of the cornea xxii

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